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Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes

Primary Purpose

Otitis Media, Pneumococcal Infections

Status

Completed

Phase

Phase 3

Locations

Finland

Study Type

Interventional

Intervention

7-valent pneumococcal-CRM197 conjugate vaccine

7-valent pneumococcal-OMPC conjugate vaccine

About this trial

This is an interventional prevention trial for Otitis Media focused on measuring Otitis Media, Pneumococcal Infections, Pneumococcal Vaccines, Proportional Hazards Models, Prospective Studies, Streptococcus pneumoniae, Vaccines, Conjugate

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

infants coming to their own child health center before the age of 13 weeks, and judged to be in good health on the basis of medical history and physical examination
family living permanently in Tampere, Kangasala or Nokia
at least one of the parents/guardians is able to communicate fluently in Finnish
written informed consent obtained from a parent/guardian prior to enrollment in the study

Exclusion Criteria:

hypersensitivity to any of the components of the vaccines used in the study,
known or suspected impairment of immunologic function,
history of invasive pneumococcal disease,
prior vaccination with any pneumococcal vaccine,
prior vaccination with hepatitis B vaccine,
contraindications to routine childhood immunizations
any medical condition in which, in the opinion of the investigator, the study procedures or vaccinations might cause risk to the health or endanger the well-being of the child

Sites / Locations

Kangasala Study Clinic
Nokia Study Clinic
Eteläinen, Keskinen, and Läntinen Study Clinic
Itäinen and Pohjoinen Study Clinic
Kaakkoinen Study Clinic

Outcomes

Primary Outcome Measures

Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine

Secondary Outcome Measures

First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine

Full Information

NCT ID

NCT00378417

First Posted

September 19, 2006

Last Updated

September 19, 2006

Sponsor

Finnish Institute for Health and Welfare

Collaborators

Merck Sharp & Dohme LLC, Wyeth-Lederle Vaccines, Pasteur Merieux Connaught

1. Study Identification

Unique Protocol Identification Number

NCT00378417

Brief Title

Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes

Official Title

Efficacy Trial in Finnish Children of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Pneumococcal Serotypes in the Vaccines

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Completed

Study Start Date

March 1995 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 1999 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Finnish Institute for Health and Welfare

Collaborators

Merck Sharp & Dohme LLC, Wyeth-Lederle Vaccines, Pasteur Merieux Connaught

4. Oversight

5. Study Description

Brief Summary

This was a randomized, double-blinded multicenter cohort study of Finnish children aged 2 to 24 months. The study was designed to evaluate the efficacy of two 7-valent pneumococcal conjugate vaccines (PncCRM and PncOMPC) parallelly, both vaccines compared with the same control vaccine (hepatitis B vaccine). The primary endpoint was culture-confirmed pneumococcal acute otitis media (AOM) episodes due to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis was that, compared to the control vaccine group, the pneumococcal conjugate vaccine would protect infants from culture confirmed AOM caused by pneumococcal serotypes in the vaccine. The efficacy of the two vaccines against any pneumococcal AOM and any AOM was also evaluated. The children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine at the age of 2, 4, 6 and 12 months and followed at study clinics established specifically for the purpose from 2 to 24 months of age. Whenever AOM was diagnosed during the follow-up, middle ear fluid was aspirated for bacterial culture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Otitis Media, Pneumococcal Infections

Keywords

Otitis Media, Pneumococcal Infections, Pneumococcal Vaccines, Proportional Hazards Models, Prospective Studies, Streptococcus pneumoniae, Vaccines, Conjugate

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

3075 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

7-valent pneumococcal-CRM197 conjugate vaccine

Intervention Type

Biological

Intervention Name(s)

7-valent pneumococcal-OMPC conjugate vaccine

Primary Outcome Measure Information:

Title

Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine

Secondary Outcome Measure Information:

Title

First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

12 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: infants coming to their own child health center before the age of 13 weeks, and judged to be in good health on the basis of medical history and physical examination family living permanently in Tampere, Kangasala or Nokia at least one of the parents/guardians is able to communicate fluently in Finnish written informed consent obtained from a parent/guardian prior to enrollment in the study Exclusion Criteria: hypersensitivity to any of the components of the vaccines used in the study, known or suspected impairment of immunologic function, history of invasive pneumococcal disease, prior vaccination with any pneumococcal vaccine, prior vaccination with hepatitis B vaccine, contraindications to routine childhood immunizations any medical condition in which, in the opinion of the investigator, the study procedures or vaccinations might cause risk to the health or endanger the well-being of the child

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juhani Eskola, MD

Organizational Affiliation

Finnish Institute for Health and Welfare

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Terhi Kilpi, MD

Organizational Affiliation

Finnish Institute for Health and Welfare

Official's Role

Study Director

Facility Information:

Facility Name

Kangasala Study Clinic

City

Kangasala

ZIP/Postal Code

36200

Country

Finland

Facility Name

Nokia Study Clinic

City

Nokia

ZIP/Postal Code

37101

Country

Finland

Facility Name

Eteläinen, Keskinen, and Läntinen Study Clinic

City

Tampere

ZIP/Postal Code

33200

Country

Finland

Facility Name

Itäinen and Pohjoinen Study Clinic

City

Tampere

ZIP/Postal Code

33500

Country

Finland

Facility Name

Kaakkoinen Study Clinic

City

Tampere

ZIP/Postal Code

33720

Country

Finland

12. IPD Sharing Statement

Citations:

PubMed Identifier

11172176

Citation

Eskola J, Kilpi T, Palmu A, Jokinen J, Haapakoski J, Herva E, Takala A, Kayhty H, Karma P, Kohberger R, Siber G, Makela PH; Finnish Otitis Media Study Group. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001 Feb 8;344(6):403-9. doi: 10.1056/NEJM200102083440602.

Results Reference

result

PubMed Identifier

14557958

Citation

Kilpi T, Ahman H, Jokinen J, Lankinen KS, Palmu A, Savolainen H, Gronholm M, Leinonen M, Hovi T, Eskola J, Kayhty H, Bohidar N, Sadoff JC, Makela PH; Finnish Otitis Media Study Group. Protective efficacy of a second pneumococcal conjugate vaccine against pneumococcal acute otitis media in infants and children: randomized, controlled trial of a 7-valent pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine in 1666 children. Clin Infect Dis. 2003 Nov 1;37(9):1155-64. doi: 10.1086/378744. Epub 2003 Oct 7.

Results Reference

result

PubMed Identifier

23658394

Citation

Ekstrom N, Ahman H, Palmu A, Gronholm S, Kilpi T, Kayhty H; FinOM Study Group. Concentration and high avidity of pneumococcal antibodies persist at least 4 years after immunization with pneumococcal conjugate vaccine in infancy. Clin Vaccine Immunol. 2013 Jul;20(7):1034-40. doi: 10.1128/CVI.00039-13. Epub 2013 May 8.

Results Reference

derived

Learn more about this trial

Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes

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